[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592660":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":41,"centralContacts":46,"locations":34,"responsibleParty":51,"collaborators":34,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":34,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":34,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":34,"overallStatus":75,"whyStopped":34,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":34},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"TVNS + Slow-Paced Breathing (TVNS+SDB)","ACTIVE_COMPARATOR","Participants receive active transcutaneous auricular vagus nerve stimulation (taVNS) using electrodes placed at the cymba conchae, combined with guided slow-paced diaphragmatic breathing (0.1 Hz). The intervention is performed daily at home for 12 weeks, with each session lasting 60 minutes.",[13],"Device: TVNS + Slow-Paced Breathing (TVNS+SDB)",{"label":15,"type":10,"description":16,"interventionNames":17},"TVNS without Breathing Training (TVNS+NB)","Participants receive active transcutaneous auricular vagus nerve stimulation (taVNS) using electrodes placed at the cymba conchae, combined with spontaneous breathing (no guided breathing exercises). The intervention is performed daily at home for 12 weeks, with each session lasting 60 minutes.",[18],"Device: TVNS without Breathing Training (TVNS+NB)",{"label":20,"type":10,"description":21,"interventionNames":22},"Sham TVNS + SDB","Participants receive transcutaneous auricular vagus nerve stimulation using a sham protocol via electrodes placed at the cymba conchae, combined with guided slow-paced diaphragmatic breathing (0.1 Hz). The intervention is performed daily at home for 12 weeks, with each session lasting 60 minutes.",[23],"Device: Sham TVNS + SDB",{"label":25,"type":26,"description":27,"interventionNames":28},"Sham TVNS + NB","SHAM_COMPARATOR","Participants receive transcutaneous auricular vagus nerve stimulation using a sham protocol via electrodes placed at the cymba conchae, combined with spontaneous breathing (no guided breathing exercises). The intervention is performed daily at home for 12 weeks, with each session lasting 60 minutes.",[29],"Device: Sham TVNS + NB",[31,35,37,39],{"type":32,"name":9,"description":11,"armGroupLabels":33,"otherNames":34},"DEVICE",[9],null,{"type":32,"name":15,"description":16,"armGroupLabels":36,"otherNames":34},[15],{"type":32,"name":20,"description":21,"armGroupLabels":38,"otherNames":34},[20],{"type":32,"name":25,"description":27,"armGroupLabels":40,"otherNames":34},[25],[42],{"name":43,"affiliation":44,"role":45},"Ali Kapan, PhD","Medical University of Vienna, Center for Public Health,","PRINCIPAL_INVESTIGATOR",[47],{"name":43,"role":48,"phone":49,"phoneExt":34,"email":50},"CONTACT","+43 01 40160 34608","ali.kapan@meduniwien.ac.at",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"SPONSOR_INVESTIGATOR","Ali Kapan","Principal Investigator","100592660","effects-of-auricular-vagus-nerve-stimulation-combined-with-slow-paced-breathing-on-individuals-with-postural-orthostatic-tachycardia-syndrome-100592660",false,"NCT06996314","Effects of Auricular Vagus Nerve Stimulation Combined With Slow-paced Breathing on Individuals With Postural Orthostatic Tachycardia Syndrome.","Effects of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Slow-Paced Diaphragmatic Breathing on Postural Tachycardia Syndrome: A Randomized Controlled Trial","Inclusion Criteria:\n\nFormal diagnosis of Postural Orthostatic Tachycardia Syndrome (POTS), confirmed by clinical criteria: a sustained increase in heart rate (HR) of ≥30 bpm within 10 minutes of standing, without orthostatic hypotension.\n\nHistory of POTS diagnosis for at least 6 months.\n\nParticipants with Post-acute COVID-19 syndrome may be included if they meet the formal POTS criteria. These participants will be stratified based on the presence or absence of Post-Exertional Malaise (PEM).\n\nStable medication for POTS (same dosage\u002Fclass) for at least 4 weeks before enrollment.\n\nWillingness and ability to provide informed consent.\n\nScreening of Undiagnosed Participants:\n\nSuspected POTS based on clinical symptoms (e.g., dizziness, fatigue, syncope, brain fog, palpitations, exercise intolerance) persisting ≥6 months.\n\nPreliminary Schellong test by study team.\n\nIf criteria are met, referral to a specialist (neurology or cardiology) for diagnostic confirmation.\n\nInclusion only after specialist-confirmed POTS diagnosis.\n\nExclusion Criteria:\n\nSignificant hypertension (BP \\>150\u002F100 mmHg supine or standing).\n\nOrthostatic hypotension: drop in BP \\>20 mmHg systolic or \\>10 mmHg diastolic upon standing.\n\nRecent stroke or myocardial infarction (within 6 months).\n\nSignificant immunological or hematological disorders.\n\nSevere anemia (hematocrit \\\u003C28%).\n\nHistory of vagotomy.\n\nPregnancy or lactation.\n\nInability or unwillingness to provide informed consent.","ALL","18 Years","65 Years",{"count":66,"type":67},100,"ESTIMATED","INTERVENTIONAL",[70],"NA","This study investigates a non-pharmacological treatment approach for Postural Orthostatic Tachycardia Syndrome (POTS), a disorder of the autonomic nervous system characterized by an excessive increase in heart rate upon standing. POTS is commonly associated with symptoms such as dizziness, fatigue, cognitive difficulties, sleep disturbances, as well as anxiety and depression, which significantly impair quality of life.\n\nThis randomized, controlled clinical trial aims to evaluate whether combining transcutaneous auricular vagus nerve stimulation (taVNS) with slow-paced diaphragmatic breathing (at 0.1 Hz) provides greater therapeutic benefit compared to taVNS alone or sham stimulation.\n\nA total of 100 participants will be recruited and randomly assigned to one of four groups (25 per group):\n\ntaVNS with slow-paced breathing,\n\ntaVNS with spontaneous (normal) breathing,\n\nsham taVNS with slow-paced breathing, or\n\nsham taVNS with spontaneous breathing.\n\nParticipants will perform the intervention daily at home for a duration of 12 weeks. Medical and psychological assessments will be conducted before and after the intervention, including measurements of heart rate, inflammatory cytokines, and patient-reported outcomes on sleep, mood, and quality of life.\n\nThe study is conducted at the Center for Public Health, Medical University of Vienna, and is open to individuals diagnosed with POTS, including those with coexisting Post-COVID-19 syndrome.",[73,74],"Postural Orthostatic Tachycardia Syndrome (POTS)","Post-acute COVID-19 Syndromes","NOT_YET_RECRUITING","2025-05-30",{"date":78,"type":79},"2025-06-04","ACTUAL",{"date":81,"type":67},"2025-09-01",{"date":83,"type":67},"2028-08-31",{"name":53,"class":6}]